Clinical trials: Bioequivalence Study
Hyperphosphatemia
Bioequivalence Study of BAY77-1931 Granule
The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first…
- Trial name
- NCT01053676
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule, Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
- Where
- Japan
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy…
- Trial name
- NCT02865668
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed…
- Trial name
- NCT01053689
- Testing
- Glimepiride tablets 1 mg
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg
"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
- Trial name
- NCT00650065
- Testing
- Cetirizine HCl Tablets 10 mg, Zyrtec® Tablets 10 mg
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.
- Trial name
- NCT07845630
- Testing
- Vicadrostat, Empagliflozin, Vicadrostat + empagliflozin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Contraception
Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill).
- Trial name
- NCT00447863
- Testing
- Levonorgestrel/Ethinyl Estradiol
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Fed
Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01618760
- Testing
- Risperidone Tablet 1 mg, Risperidone
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets
This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single…
- Trial name
- NCT02373046
- Testing
- LX4211
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Peripheral Arterial Disease
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
To evaluate the bioequivalence and safety of AJU-B718 and B718R in Healthy Adults.
- Trial name
- NCT07901088
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
Healthy
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00684723
- Testing
- Lovastatin 40 mg Tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Type2diabetes
Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus…
- Trial name
- NCT06450262
- Testing
- Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets, Synjardy® 12.5mg/1000mg film-coated tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT03702855
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
- Trial name
- NCT02372097
- Testing
- SYR-472
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Fasting
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under…
- Trial name
- NCT01283841
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Magicbuvir Plus 90/400 mg Tablets (Magic…
- Trial name
- NCT03005210
- Testing
- Magicbuvir Plus, Harvoni (fist dose), Harvoni (second dose)
- Where
- Egypt
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
- Trial name
- NCT00849797
- Testing
- Oxcarbazepine, Trileptal®
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on After Meals in Healthy Subjects
In order to evaluate the bioequivalence of the test preparation and reference preparation of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
- Trial name
- NCT04556110
- Testing
- Perindopril tert-Butylamine tablets （ Produced by Haisco）, Perindopril tert-Butylamine tablets（ACERTIL®）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy
Oral Bioavailability of Bilastine
The purpose of this study is to assess the absolute bioavailability of an oral bilastine formulation (test drug) compared to the endovenous administration of an IV bilastine formulation (control drug) in healthy volunteers.
- Trial name
- BIOBI (NCT01124123)
- Testing
- Bilastine
- Where
- Spain
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Faes Farma, S.A.
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
- Trial name
- NCT01101191
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy Vollunteer
Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions
Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions Study…
- Trial name
- NCT06297174
- Testing
- Racecadotril 100 mg Capsules, HIDRASEC®
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pharma Nueva